Our accurate and secure document management enables companies to maintain regulatory compliance and optimize internal processes.
Our expertise in ensuring strict compliance with international regulations, supported by a systematic approach. Aligned with the highest global standards, such as:
IEC 62304
Medical Device Software Software Life Cycle Processes
ISO 14971
Medical Devices Application of Risk Management to Medical Devices
IEC 62366
Medical Device Software Usability Engineering Processes
Too many medical device manufacturers expose themselves to weaknesses and vulnerabilities by not aligning their processes with ISO and IEC standards. This results in a backlog for development and, more importantly, a longer time-to-market.
9001: 2015
13485: 2016
Kaira Engineering, the perfect partner for all MedTech companies that need professional consultancy services to keep up to date with the latest trends and requirements of the medical industry.